A Study Evaluating the Addition of MabThera (Rituximab) to Standard Treatment in Patients With Idiopathic Thrombocytopenic Purpura (ITP)

October 21, 2014 updated by: Hoffmann-La Roche

A Randomized, Open-label Study of First-line Treatment With Dexamethasone or Dexamethasone Plus MabThera on Sustained Treatment Response in Adult Patients With Idiopathic Thrombocytopenic Purpura

This study will compare the efficacy, safety, and pharmacokinetics of standard treatment versus standard treatment plus MabThera in patients with ITP. The anticipated time on study treatment is <3 months, and the target sample size is 100-500 individuals.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Bari, Italy, 70124
      • Bologna, Italy, 40138
      • Brescia, Italy, 25123
      • Cagliari, Italy, 09121
      • Cuneo, Italy, 12100
      • Genova, Italy, 16132
      • Milano, Italy, 20162
      • Napoli, Italy, 80131
      • Padova, Italy, 35128
      • Palermo, Italy, 90146
      • Pavia, Italy, 27100
      • Pesaro, Italy, 61100
      • Pescara, Italy, 65100
      • Ravenna, Italy, 48100
      • Reggio Emilia, Italy, 42100
      • Roma, Italy, 00161
      • Roma, Italy, 00168
      • Roma, Italy, 00133
      • Siena, Italy, 53100
      • Taranto, Italy, 74100
      • Udine, Italy, 33100
      • Verona, Italy, 37130

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • adult patients >=18 years of age;
  • untreated ITP.

Exclusion Criteria:

  • ITP with relapse;
  • positive test result for HIV or hepatitis B or C;
  • active infection requiring systemic therapy;
  • malignancy within 3 years before study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Dexamethasone
Participants received 40 milligrams (mg) dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of less than or equal to (≤)20 x 10^9 platelets per liter (L; from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg per square meter (mg/m^2), intravenously (IV), with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28.
Drug: Dexamethasone
Experimental: Dexamethasone plus Rituximab
Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets less than (<) 20 x10^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m^2, IV on Days 7, 14, 21, and 28 administered with immunoglobulin (IgG) IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
Drug: rituximab
Other Names:
  • MabThera/Rituxan
Drug: Dexamethasone

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With a Sustained Response
Time Frame: Week 24
Sustained response defined as a platelet count of greater than or equal to (≥) 50x10^9/L at 6 months (Week 24) after the initial treatment. Participants failing therapy before Month 6 (Week 24) and treated in other ways were considered failures.
Week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With an Initial Response
Time Frame: Week 4
Initial response was defined as an increase in platelet count of ≥50x10^9/L by Day 30 (Week 4) after the start of treatment in either treatment arm.
Week 4
Percentage of Participants With an Initial Complete Response
Time Frame: Week 4
Initial complete response was defined as an increase in platelet count of ≥100x10^9/L by Day 30 (Week 4) after the initiation of treatment in either treatment arm.
Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2005

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

October 9, 2008

First Submitted That Met QC Criteria

October 9, 2008

First Posted (Estimate)

October 10, 2008

Study Record Updates

Last Update Posted (Estimate)

October 22, 2014

Last Update Submitted That Met QC Criteria

October 21, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML18542

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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